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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceIS-1 CONNECTOR TERMINAL OF SELUTE/PICOTIP BIPOLAR LEADS
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP950001
Supplement NumberS006
Date Received04/17/2000
Decision Date05/19/2000
Product Code DTB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for: 1) use of a new mechanically interlocking component design to connect the terminal pin to the terminal ring, and 2) use of a shorter IS-1 connector terminal.
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